Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06630299
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-04
Brief Title:
Study to Compare an Oral Weekly IslatravirLenacapavir Regimen With Standard of Care in Virologically Suppressed People With HIV-1
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 3 Randomized Open-Label Active-Controlled Study to Evaluate a Switch to an Oral Weekly IslatravirLenacapavir Regimen in People With HIV-1 Who Are Virologically Suppressed on Standard of Care
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ISLEND-2
Brief Summary:
The goal of this clinical study is to learn more about the safety and efficacy of switching to a once weekly tablet of islatravirlenacapavir ISLLEN regimen versus continuing standard of care treatment in people with human immunodeficiency virus PWH who are virologically suppressed HIV-1 RNA levels 50 copiesmL on a stable standard of care regimen for 6 months prior to screening The standard of care includes 2 or 3 medicines antiretroviral agents ARVs
The primary objective of the study is to evaluate the efficacy of switching to oral weekly ISLLEN tablet regimen versus continuing standard of care in virologically suppressed PWH at Week 48
The primary objective of the study is to evaluate the efficacy of switching to oral weekly ISLLEN tablet regimen versus continuing standard of care in virologically suppressed PWH at Week 48
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None